G/SPS/N/EU/637  
26 May 2023  
(23-3627) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -
General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Lacto -N-neotetraose  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Commission Implementing Regulation (EU) 2023/961 
of 12 May 2023 amending Implementing Regulation (EU) 2017/2470 as regards the 
conditions of use of the novel food Lac to-N-neotetraose (Text with EEA relevance) . 
Language(s):  English, French and Spanish . Number of pages:  5 
https://members.wto.org/crnattachments/2023/SPS/EEC/23_09838_00_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_09838_00_f.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_09838_00_s.pdf  
6. Description of content:  The measure authorizes the change in the conditions of use of 
Lacto -N-neotetraose to be used in infant formula and follow -on formula at the currently 
authorized levels of up to 0,6 g/l, without the obligatory use in combination with 2′ -
Fucosyllactose at a 1:2 use ratio (one part Lacto -N-neotetraose with two parts 2′ -
Fucosyllactose). Also, the measure removes the obligatory use of Lacto -N-neotetraose in 
combination with 2′ -Fucosyllactose at a 1:2 use ratio in milk -based drinks and similar 
products intended for young children without when the two novel foods are added 
separately.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant pr otection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  G/SPS/N/EU/637  
 
- 2 - 
 
  [ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : 12 May 2023  
Proposed date of publication (dd/mm/yy) : 16 May 2023  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : 5 June 2023  
[X] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if available) of other body:   
European Commission  
DG Health and Food Safety, Unit A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
European Commission  
DG Health and Food Safety, Unit A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu